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EC number: -
CAS number: -
mutagenicity of the test substance in bacteria was assessed using a test
method was designed to be compatible with OECD
Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation
strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain
WP2uvrA were treated with solutions of the test substance using
both the Ames plate incorporation and pre-incubation methods at up to
eight dose levels, in triplicate, both with and without the addition of
a rat liver homogenate metabolising system (10% liver S9 in standard
co-factors) over four separate experiments (two experiments with two
further confirmatory experiments).
dose range for Experiment 1 (plate incorporation) was 1.5 to 5000 mg/plate. The
experiment was repeated on a separate day (pre-incubation method) using
a dose range that ranged between 0.15 and 5000 µg/plate, depending on
the strain type and presence or absence metabolic activation (S9). An
expanded dose range was selected in Experiment 2 in order to achieve
both four non-toxic dose levels and the toxic limit of the test item.
to differences in the results obtained in Experiments 1 and 2, a confirmatory
test (Confirmatory Test 1) was dosed at 5 to 500 µg/plate using TA1535
(in the presence of S9-mix only) under pre-incubation conditions only. A
second confirmatory experiment (Confirmatory Test 2) was dosed, again
using TA1535, with and without S9-mix and using both plate incorporation
and pre-incubation methods to confirm the difference in results obtained
in Experiment 2 and Confirmatory Test 1. The
dose range was the same as Confirmatory Test 1.
vehicle (dimethyl sulphoxide (DMSO)) control plates gave counts of
revertant colonies within the normal range. All
of the positive control chemicals used in the test induced marked
increases in the frequency of revertant colonies, both with or without
metabolic activation. Thus,
the sensitivity of the assay and the efficacy of the S9-mix were
analysis of the results of all the experiments, it was concluded that no
biologically relevant increases in the frequency of revertant colonies
were observed at any dose of the test item, either with or without
metabolic activation (S9-mix).
test item precipitate was observed on the plates at any of the doses
tested in either the presence or absence of S9-mix in any of the
experiments detailed above.
test substance was considered to be non-mutagenic under the conditions
of this test.
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